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U.S. Department of Health and Human Services

Class 2 Device Recall AMS DURAII Distil Tips

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  Class 2 Device Recall AMS DURAII Distil Tips see related information
Date Initiated by Firm February 19, 2007
Date Posted April 03, 2007
Recall Status1 Terminated 3 on June 27, 2007
Recall Number Z-0702-2007
Recall Event ID 37615
510(K)Number K953640  
Product Classification Penile Prosthesis Tip Extenders - Product Code FAE
Product AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
Code Information Lot 475177
Recalling Firm/
Manufacturer		 American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
Manufacturer Reason
for Recall		 Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
FDA Determined
Cause 2		 Other
Action The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
Quantity in Commerce 5 devices
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FAE and Original Applicant = DACOMED CORP.
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